|Over a month ago|
Oncolytics's pelareorep to be tested in Phase 2 breast cancer trial » 07:1706/2506/25/20
Oncolytics (ONCY) announced a new investigator-sponsored triple-negative breast cancer study to be managed by Rutgers Cancer Institute of New Jersey. The phase 2 trial, known as IRENE, will investigate the use of pelareorep in combination with Incyte's (INCY) anti-PD-1 checkpoint inhibitor retifanlimab in patients with unresectable locally advanced or metastatic TNBC. The IRENE study represents an expansion of Oncolytics' lead breast cancer program into a new disease subtype. Systemic pelareorep administration has the potential to increase the number of patients that are eligible for checkpoint inhibitor therapy
Oncolytics announces dosing of first patient in phase 2 of Bracelet-1 study » 07:1206/2306/23/20
ONCY, PFE, MRK
Oncolytics Biotech (ONCY)…
Oncolytics Biotech (ONCY) announced the first patient has been dosed in the Company's phase 2 study of pelareorep-based combination therapies in HR+/HER2- metastatic breast cancer, or mBC. The study, known as BRACELET-1, is being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business in the US and Canada as EMD Serono, and Pfizer (PFE). Participants in the study receive paclitaxel, pelareorep in combination with paclitaxel alone, or pelareorep in combination with paclitaxel and Merck (MRK) KGaA, Darmstadt, Germany and Pfizer's anti-PD-L1 checkpoint inhibitor, avelumab. The randomized BRACELET-1 study is designed to support the results of a prior successful phase 2 trial that showed a near doubling of overall survival with pelareorep treatment, by demonstrating pelareorep's ability to induce a robust anti-tumor immune response in an identical patient population.
Oncolytics files C$150M mixed securities shelf 17:2806/0806/08/20
Oncolytics: ePoster published from phase 1b study of pelareorep-carfilzomib » 07:1005/2905/29/20
Oncolytics announced the…
Oncolytics announced the publication of an electronic-poster with clinical proof-of-concept data from the company's phase 1b study in carfilzomib-refractory multiple myeloma patients treated with pelareorep in combination with carfilzomib. Data presented in the ePoster demonstrates that the pelareorep-carfilzomib combination treatment results in selective replication of pelareorep in cancer cells and beneficial induction of an inflamed tumor environment associated with clinical responses. The ePoster was published this morning and will be presented this weekend as part of the American Society of Clinical Oncology Virtual Annual Meeting.
Oncolytics presents data from AWARE-1 cancer study » 07:0305/2605/26/20
Oncolytics Biotech announced the publication of an electronic-poster with clinical data from the company's AWARE-1 window-of-opportunity breast cancer study. The data demonstrates a pelareorep-induced adaptive immune response in the tumor microenvironment and the potential of a predictive biomarker to identify patients with breast cancer most likely to respond to pelareorep. The ePoster was published on May 23, and presented over the weekend, as part of the European Society for Medical Oncology Breast Cancer Virtual Meeting. "The preliminary AWARE-1 data showing a pelareorep-induced adaptive immune response in the tumor microenvironment are highly encouraging and strongly support the trial design and rationale," said Dr. Aleix Prat, co-author and lead translational investigator for the AWARE-1 study. "Observed increases in CelTIL, which are associated with a favorable response to treatment, are particularly noteworthy. Additionally, I am especially excited by data supporting the use of T cell clonality as a predictive and prognostic biomarker of pelareorep response, as the ability to accurately identify patients most likely to respond favorably to treatment will facilitate the success of future trials."
Oncolytics price target lowered to C$6 from C$9 at RBC Capital » 12:2105/1105/11/20
RBC Capital analyst…
RBC Capital analyst Douglas Miehm lowered the firm's price target on Oncolytics to C$6 from C$9 and keeps an Outperform rating on the shares following the company's Q1 earnings results.
|Over a quarter ago|
Oncolytics expects COVID-19 to impact clinical trial enrollment » 17:1704/1704/17/20
Oncolytics Biotech, currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, provided an update on the potential impact of COVID-19 on the company's clinical and business operations. The Company's clinical and regulatory teams remain active and are working closely with investigators to identify the most appropriate steps forward for each study. There has been no impact on the continuity of the manufacturing of pelareorep, and Oncolytics is fully capable of supplying pelareorep to all ongoing clinical studies. Although it is too early to determine the absolute effects of the outbreak on specific trial timelines, it is anticipated that COVID-19 will impact clinical trial enrollment timelines to some degree.
Oncolytics' pelareorep shows positive safety and efficacy results in publication » 07:0504/0204/02/20
Oncolytics, currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, announced clinical data published in a peer-reviewed journal highlighting that the combination of FOLFIRI, bevacizumab and pelareorep was well tolerated, with promising efficacy signals in colorectal cancer patients with KRAS mutated tumors. The article was published on March 10 in Molecular Cancer Therapeutics. The study enrolled 36 patients with KRAS mutation in a dose-escalation trial, of which 30 patients were assessable for response. The combination of FOLFIRI, bevacizumab and pelareorep was well tolerated, with promising signals of efficacy. Six patients received the recommended phase 2 dose, at which a 50% overall response rate and a median overall survival of 25.1 months were observed, which compares favorably to the historical OS of 13.5 months, an 86% improvement. Among 30 evaluable patients, 6 had a partial response and 22 patients had stable disease as their best response, for a clinical benefit rate of 93.3%. Enhanced efficacy elicited by the administration of pelareorep was supported by evidence of an adaptive immune response occurring after each cycle of pelareorep treatment. These immune responses were only seen after pelareorep administration and not with the other medications alone, strongly suggesting that pelareorep is influencing these responses.
Oncolytics announces assesment of AWARE-1 from Safety Committee » 07:0503/2403/24/20
Oncolytics Biotech announced a favourable assessment from the Safety Committee following review of data from the window of opportunity study in early-stage breast cancer, known as AWARE-1. Consistent with the safety run-in with patients receiving pelareorep and Tecentriq, Cohort 1 demonstrated widespread viral replication in the majority of tumors with the creation of a pro-inflammatory effect in the tumor microenvironment. No negative effects to healthy tissue were noted. The Committee evaluated safety parameters from patients participating in the safety run-in phase of the trial, consisting of select patients from cohorts 2 and 3, along with the fully enrolled cohort 1, and determined there were no safety concerns. The Committee also approved an amendment of the study to reduce the dose of Tecentriq to be consistent with the currently approved breast cancer dose of 840mg. The study will continue to enroll patients and the Safety Committee will meet again for an additional pre-planned meeting. Cohorts 1 and 2 represent our target tumor type of HR+ / HER2- and data from these patients will inform the design of the planned phase 3.
Oncolytics: Data identifies CEACAM6 as a prospective biomarker for pelareorep » 07:0401/2701/27/20
Oncolytics Biotech announced that a poster presentation highlighting statistically significant data identifying CEACAM6 as a prospective biomarker for pelareorep in the treatment of pancreatic cancer. The presentation was delivered at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO in San Francisco. "We have identified another biomarker candidate for pelareorep," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "These results correlate CEACAM6 levels with long term benefit in patients with pancreatic cancer. We are working with industry and academic colleagues to verify this important finding not only in pancreatic cancer but potentially in other GI indications where this biomarker is linked to clinical outcomes."